Alzheimer Disease Clinical Trial
Official title:
A Non-Blinded, Non-Significant Risk Study With a Non-Invasive, Passive Pressure Wave Method of Diagnosing Brain Pathologies to Develop a Diagnostic Algorithm for Alzheimer Disease and Other Dementias.
NCT number | NCT02333942 |
Other study ID # | 082189 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | February 2015 |
Verified date | September 2019 |
Source | Jan Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is being performed to generate data regarding brain vibration /oscillation differences between individuals with dementia and normal controls. The purpose of this study is to compare signal patterns generated from the impact on the scalp from these brain oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female subjects 18 years of age or older 2. Have undergone some neurologic imaging 3. Age match normal subjects and subjects with symptoms consistent with MCI, FTLD or Alzheimer's disease 4. Able to understand and provide signed informed consent, or have a legally authorized representative willing to provide informed consent on subject's behalf Exclusion Criteria: 1. Psychologically unstable and not able to cooperate 2. Not suitable for participation in this study in the opinion of the PI 3. Patients with history of other cerebral pathologies including, head trauma or prior ICH |
Country | Name | City | State |
---|---|---|---|
United States | University of Californa San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jan Medical, Inc. | University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity as a diagnostic aid in detecting Dementia (identified signatures as compared with the clinical assessment made by the PI) | Efficacy at identifying Dementia through identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive at assessment. | one year | |
Primary | Specificity as a diagnostic aid in detecting Dementia (Rate of false positives as compared with the clinical assessment made by the PI) | Rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment. | one year | |
Secondary | Sensitivity and specificity measures for MCI and Alzheimer's disease (Efficacy and rate of false positives as compared with the clinical assessment made by the PI) | Efficacy and rate of false positives as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment. | one year | |
Secondary | Sensitivity and specificity measures between MCI and FTDL. (distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI) | To distinguish between MCI and FTDL using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment. | one year | |
Secondary | Sensitivity and specificity measures between FTDL and Alzheimer's disease (distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI) | To distinguish between FTLD and Alzheimer's disease using efficacy and rate of false positives from the identified signatures as compared with the clinical assessment made by the PI and any objective measures the PI uses to arrive as assessment. | one year |
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